Comparison the effect of intercostal nerve block added infusion of intravenous morphine versus infusion of intravenous morphine only for pain control after open cholecystectomy
The aim of this study is to compare the efficacy of intercostal nerve block added intravenous infusion of morphine with intravenous morphine for pain control after open cholecystectomy. in 100 patients who are candidate for open cholecystectomy randomized divided in tow 50 groups. The patients underwent elective cholecystectomy were randomly allocated to any of the following two groups comprising of 50 patients each group.
Group intervention was allocated for intercostal nerve block with 0.25 milligrams per kilogram of bupivacaine diluted in 2.5 milligrams per milliliter was infiltrated in the subcostal 6 to 10 rib margin then intravenous Patient-controlled analgesia with 0.5 milligrams per kilogram morphine started. In control Group patients had intravenous Patient-controlled analgesia with only 0.5 milligrams per kilogram morphine. the infusion rate is 5 milliliters per hour.
When the patients shifted to postoperative recovery room where intensity of pain was recorded by response from the patients using 100 mm linear visual analogue scale (VAS) ranging from 0 to 100. The pain scoring was done at 30 minutes, 6 hours, 12 hours, 18 hours and 24 hours postoperatively.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014120320112N2
Registration date:2014-12-15, 1393/09/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-15, 1393/09/24
Registrant information
Name
Pooya Derakhshan
Name of organization / entity
Birjand Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3234 1410
Email address
pooya_derakhshan@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University Of Medical Sciences
Expected recruitment start date
2009-04-23, 1388/02/03
Expected recruitment end date
2013-03-21, 1392/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of intercostal nerve block added infusion of intravenous morphine versus infusion of intravenous morphine only for pain control after open cholecystectomy
Public title
Effect of intercostal nerve block on the pain after open cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: American society of anesthesiologist class 1 and 2; age 20-60 year
exclusion criteria: addiction to opium and sedative drugs; epilepsy
Age
From 27 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Birjand University of Medical Sciences
Street address
N:56, Ghafari Ave.
City
Birjand
Postal code
1973456783421589
Approval date
2009-04-23, 1388/02/03
Ethics committee reference number
5_2_1388
Health conditions studied
1
Description of health condition studied
Calculus of bile duct without cholangitis or cholecystitis
ICD-10 code
K80.5
ICD-10 code description
Calculus of bile duct without cholangitis or cholecystitis
Primary outcomes
1
Description
pain
Timepoint
in 30th minute and every 6 houre
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
in control group intercostal nerve block with 0.25 milligrams per kilogram bupivacaine diluted to 2.5 milligrams per milliliter injected in 6th to 10th subcostal margin and then the infusion of intravenous morphine 0.5 milligrams per kilogram start at infusion rated 5 milliliters per hour.
Category
Treatment - Drugs
2
Description
infusion of intravenous morphine 0.5 milligrams per kilogram start at infusion rated 5 milliliters per hour
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Pooya Derakhshan
Street address
Imam Reza Hostipal, Taleghani St.
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hasan Karbasi
Street address
Ghafari Ave.
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Pooya Derakhshan
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Taleghani St.
City
Birjand
Postal code
1974567321566549
Phone
+98 563222600
Fax
Email
pooyaderakh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Pooya Derakhshan
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Talegani St.
City
Birjand
Postal code
Phone
+98 563222600
Fax
Email
pooyaderakh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Pooya Derakhshan
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Taleghani St.
City
Birjand
Postal code
1974567894321132
Phone
+98 563222600
Fax
Email
pooyaderakh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)